{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20190506",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58587",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s013lbl.pdf",
              "date": "20190507",
              "type": "Label"
            },
            {
              "id": "58611",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s013ltr.pdf",
              "date": "20190508",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "58",
          "submission_status": "AP",
          "submission_status_date": "20251002",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "83649",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761034s058lbl.pdf",
              "date": "20251003",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20180626",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54720",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s011lbl.pdf",
              "date": "20180628",
              "type": "Label"
            },
            {
              "id": "54851",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s011ltr.pdf",
              "date": "20180706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "62",
          "submission_status": "AP",
          "submission_status_date": "20260512",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "85904",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761034Orig1s062ltr.pdf",
              "date": "20260513",
              "type": "Letter"
            },
            {
              "id": "85940",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761034s062lbl.pdf",
              "date": "20260518",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20180614",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "54633",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034s008ltr.pdf",
              "date": "20180620",
              "type": "Letter"
            },
            {
              "id": "54667",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s008lbl.pdf",
              "date": "20180621",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20210217",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "66273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf",
              "date": "20210218",
              "type": "Label"
            },
            {
              "id": "66289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf",
              "date": "20210218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "20211006",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "68910",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s044ltr.pdf",
              "date": "20211007",
              "type": "Letter"
            },
            {
              "id": "68959",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s044lbl.pdf",
              "date": "20211012",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20210217",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "66271",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf",
              "date": "20210218",
              "type": "Label"
            },
            {
              "id": "66291",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf",
              "date": "20210218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "50",
          "submission_status": "AP",
          "submission_status_date": "20221202",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "72785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s050lbl.pdf",
              "date": "20221205",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20200730",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "64150",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s028lbl.pdf",
              "date": "20200730",
              "type": "Label"
            },
            {
              "id": "64154",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s028ltr.pdf",
              "date": "20200731",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "42",
          "submission_status": "AP",
          "submission_status_date": "20211015",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "69038",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s042ltr.pdf",
              "date": "20211020",
              "type": "Letter"
            },
            {
              "id": "69075",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034Orig1s042lbl.pdf",
              "date": "20211022",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20210217",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "66269",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf",
              "date": "20210218",
              "type": "Label"
            },
            {
              "id": "66288",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf",
              "date": "20210218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20190308",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "57936",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s018lbl.pdf",
              "date": "20190308",
              "type": "Label"
            },
            {
              "id": "57938",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s018ltr.pdf",
              "date": "20190308",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20201218",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65684",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s031, s032ltr.pdf",
              "date": "20201222",
              "type": "Letter"
            },
            {
              "id": "65727",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s031s032lbl.pdf",
              "date": "20201223",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160518",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "40639",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf",
              "date": "20160518",
              "type": "Label"
            },
            {
              "id": "43552",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000TOC.html",
              "date": "20160621",
              "type": "Review"
            },
            {
              "id": "10662",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761034Orig1s000ltr.pdf",
              "date": "20160519",
              "type": "Letter"
            },
            {
              "id": "24538",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761034Orig1s000SumR.pdf",
              "date": "20160621",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20190506",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58585",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s014lbl.pdf",
              "date": "20190507",
              "type": "Label"
            },
            {
              "id": "58612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s014ltr.pdf",
              "date": "20190508",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20201110",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "65188",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s020ltr.pdf",
              "date": "20201112",
              "type": "Letter"
            },
            {
              "id": "65219",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s020lbl.pdf",
              "date": "20201113",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "59",
          "submission_status": "AP",
          "submission_status_date": "20251117",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "84190",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761034s059lbl.pdf",
              "date": "20251118",
              "type": "Label"
            },
            {
              "id": "84202",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761034Orig1s059ltr.pdf",
              "date": "20251118",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20180702",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "54739",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s012lbl.pdf",
              "date": "20180702",
              "type": "Label"
            },
            {
              "id": "54797",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s012ltr.pdf",
              "date": "20180706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "57",
          "submission_status": "AP",
          "submission_status_date": "20250818",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "83136",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761034Orig1s057ltr.pdf",
              "date": "20250819",
              "type": "Letter"
            },
            {
              "id": "83144",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761034s057lbl.pdf",
              "date": "20250820",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20180619",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "54614",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s010lbl.pdf",
              "date": "20180620",
              "type": "Label"
            },
            {
              "id": "54649",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s010ltr.pdf",
              "date": "20180621",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "49",
          "submission_status": "AP",
          "submission_status_date": "20230512",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74244",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761034Orig1s049,s051ltr.pdf",
              "date": "20230515",
              "type": "Letter"
            },
            {
              "id": "74251",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761034s049s051lbl.pdf",
              "date": "20230515",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20181206",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "56640",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s009lbl.pdf",
              "date": "20181206",
              "type": "Label"
            },
            {
              "id": "56826",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s009ltr_REPLACEMENT.pdf",
              "date": "20190312",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "47",
          "submission_status": "AP",
          "submission_status_date": "20221209",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "72856",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s047lbl.pdf",
              "date": "20221212",
              "type": "Label"
            },
            {
              "id": "72864",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761034Orig1s047ltr.pdf",
              "date": "20221212",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "61",
          "submission_status": "AP",
          "submission_status_date": "20260515",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "85964",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761034Orig1s061ltr.pdf",
              "date": "20260519",
              "type": "Letter"
            },
            {
              "id": "85973",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761034s061lbl.pdf",
              "date": "20260519",
              "type": "Label"
            },
            {
              "id": "85999",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761034s061lbl.pdf#page=76",
              "date": "20260521",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "20240422",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78208",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761034Orig1s053ltr.pdf",
              "date": "20240423",
              "type": "Letter"
            },
            {
              "id": "78255",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf",
              "date": "20240425",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20180313",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52965",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s005lbl.pdf",
              "date": "20180314",
              "type": "Label"
            },
            {
              "id": "52989",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s005ltr.pdf",
              "date": "20180315",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20210217",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "66272",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf",
              "date": "20210218",
              "type": "Label"
            },
            {
              "id": "66290",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf",
              "date": "20210218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "51",
          "submission_status": "AP",
          "submission_status_date": "20230512",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "74245",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761034Orig1s049,s051ltr.pdf",
              "date": "20230515",
              "type": "Letter"
            },
            {
              "id": "74252",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761034s049s051lbl.pdf",
              "date": "20230515",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20200930",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "64785",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s029ltr.pdf",
              "date": "20201001",
              "type": "Letter"
            },
            {
              "id": "64814",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s029lbl.pdf",
              "date": "20201002",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20180430",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "53999",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761034Orig1s003ltr.pdf",
              "date": "20180503",
              "type": "Letter"
            },
            {
              "id": "54008",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761034s003lbl.pdf",
              "date": "20180503",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20220121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69960",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761034Orig1s043ltr.pdf",
              "date": "20220125",
              "type": "Letter"
            },
            {
              "id": "69965",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761034s043lbl.pdf",
              "date": "20220125",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20210217",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "66270",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf",
              "date": "20210218",
              "type": "Label"
            },
            {
              "id": "66292",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf",
              "date": "20210218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170417",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "48094",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761034s001lbl.pdf",
              "date": "20170424",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20200518",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "63085",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s027lbl.pdf",
              "date": "20200518",
              "type": "Label"
            },
            {
              "id": "63106",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s027ltr.pdf",
              "date": "20200519",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20210413",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "67055",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s041ltr.pdf",
              "date": "20210414",
              "type": "Letter"
            },
            {
              "id": "67076",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s041lbl.pdf",
              "date": "20210416",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20190318",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58028",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s019lbl.pdf",
              "date": "20190319",
              "type": "Label"
            },
            {
              "id": "58070",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s019ltr.pdf",
              "date": "20190325",
              "type": "Letter"
            },
            {
              "id": "65834",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761034Orig1s019.pdf",
              "date": "20210106",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20210217",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "66268",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s033s034s035s036s037s038lbl.pdf",
              "date": "20210218",
              "type": "Label"
            },
            {
              "id": "66287",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761034Orig1s033, s034, s035, s036, s037, s038ltr.pdf",
              "date": "20210218",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20200529",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63352",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s025lbl.pdf",
              "date": "20200529",
              "type": "Label"
            },
            {
              "id": "63388",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s025ltr.pdf",
              "date": "20200602",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20201218",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65683",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761034Orig1s031, s032ltr.pdf",
              "date": "20201222",
              "type": "Letter"
            },
            {
              "id": "65724",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s031s032lbl.pdf",
              "date": "20201223",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20191203",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "61140",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761034s021lbl.pdf",
              "date": "20191203",
              "type": "Label"
            },
            {
              "id": "61146",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761034Orig1s021ltr.pdf",
              "date": "20191204",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "BLA761034",
      "sponsor_name": "GENENTECH INC",
      "openfda": {
        "application_number": [
          "BLA761034"
        ],
        "brand_name": [
          "TECENTRIQ"
        ],
        "generic_name": [
          "ATEZOLIZUMAB"
        ],
        "manufacturer_name": [
          "Genentech, Inc."
        ],
        "product_ndc": [
          "50242-917",
          "50242-918"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ATEZOLIZUMAB"
        ],
        "rxcui": [
          "1792780",
          "1792785",
          "2119695",
          "2119696"
        ],
        "spl_id": [
          "4b922b35-c401-4189-a8b2-9f9a820878db"
        ],
        "spl_set_id": [
          "6fa682c9-a312-4932-9831-f286908660ee"
        ],
        "package_ndc": [
          "50242-917-01",
          "50242-917-86",
          "50242-918-01"
        ],
        "nui": [
          "N0000191260",
          "N0000191259",
          "M0556300",
          "M0001357",
          "M0001352"
        ],
        "pharm_class_epc": [
          "Programmed Death Receptor-1 Blocking Antibody [EPC]"
        ],
        "pharm_class_moa": [
          "Programmed Death Receptor-1-directed Antibody Interactions [MoA]"
        ],
        "pharm_class_cs": [
          "Antibodies, Monoclonal, Humanized [CS]",
          "Antibodies, Monoclonal [CS]",
          "Antibodies [CS]"
        ],
        "unii": [
          "52CMI0WC3Y"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "TECENTRIQ",
          "active_ingredients": [
            {
              "name": "ATEZOLIZUMAB",
              "strength": "1200MG/20ML"
            }
          ],
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}